FoundationOne CDx Test Results — Class II medical device recall Z-0649-2019
Terminated recall by Foundation Medicine, Inc., reported 2018-12-26, distributed nationwide. An incorrect test result for a single analyte may have been reported for up to 800 physician reports
| Recall number | Z-0649-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Foundation Medicine, Inc., Cambridge, MA, United States |
| Recall initiated | 2018-10-31 |
| Classified | 2018-12-20 |
| Reported by FDA | 2018-12-26 |
| Terminated | 2020-04-17 |
| Distributed | Nationwide (US) |
| Quantity | 800 reports |
Product
FoundationOne CDx Test Results
Reason for recall
An incorrect test result for a single analyte may have been reported for up to 800 physician reports
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0649-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.